These were the results obtained in phase 3 of an international multicentre clinical trial in which the University Hospital of Navarra took part. The research was published by The New England Journal of Medicine and in which hospitals from 15 countries and 1,199 patients participated.
In fact, as Doctor Ignacio Gil Bazo, specialist at the Department of Oncology of the University Hospital of Navarra stated, “these highly spectacular results caused an unexpected suspension of the clinical trials and patients taking placebos were offered the opportunity of receiving enzalutamide”.
This was research led by the Memorial Sloan-Kettering Cancer Center of New York and in which hospitals from 15 countries and 1,199 patients participated. The results were published last September in the North American New England Journal of Medicine.
In concrete, the trials focused on studying the effects of a new oral hormonal treatment called enzalutamide and aimed at patients with metastatic prostate cancer resistant to castration (i.e. which continues to grow despite hormonal therapy maintaining testosterone at low levels) and who had previously received chemotherapy treatment.
Enhancement in all parameters studied
“Of the total number of participants in the trials, 800 received a daily dose of 160 milligrams of enzalutamide and the other 399 took the placebo”, explained Dr Gil, lead researcher for the University Hospital of Navarra; also taking part as monitor was Nurse Elena Navarcorena Zabalza, from the Clinical Trials Unit at the Department of Oncology.
Apart from the results, Doctor Gil outlined the advantages of this hormonal treatment: “it has less toxicity than chemotherapy, it is orally administered —160 mg. daily — and has very few side effects, such as fatigue or a stifling sensation, and which the patient is already aware of, having taken other hormonal drug treatment previously”.
As regards the effects, highlighted is “the improvement in all the parameters studied”, specified in “a significant and relevant increase in global survival”. Likewise, the Hospital specialist continued, the research showed that treatment with enzalutamide reduces the PSA (prostate-specific antigen) level by more than 50% amongst most patients. “It likewise improves the response rate for soft tissue injuries, such as ganglia, liver injuries, etc.; the quality of life is enhanced; the time between PSA peak episodes is longer; as is the period until the first skeletal event linked to the diseases occurs, e.g. bone break”.
Farmakologia, Medikuntza, Osasuna Go to top of page
- Internet reference
- Howard I. Scher, M.D., Karim Fizazi, M.D., Ph.D., Fred Saad, M.D., Mary-Ellen Taplin, M.D., Cora N. Sternberg, M.D., Kurt Miller, M.D., Ronald de Wit, M.D., Peter Mulders, M.D., Ph.D., Kim N. Chi, M.D., Neal D. Shore, M.D., Andrew J. Armstrong, M.D., Thomas W. Flaig, M.D., Aude Fléchon, M.D., Ph.D., Paul Mainwaring, M.D., Mark Fleming, M.D., John D. Hainsworth, M.D., Mohammad Hirmand, M.D., Bryan Selby, M.S., Lynn Seely, M.D., and Johann S. de Bono, M.B., Ch.B., Ph.D. for the AFFIRM Investigators. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med 2012; 367:1187-1197September 27, 2012DOI: 10.1056/NEJMoa1207506.
- Additional information